Biosimilars FAQ for Patients

Biologic (originator) drugs are made using living organisms (e.g., yeast or animal cells) rather than being synthetically manufactured and are used to treat patients with serious chronic conditions.

When patents on biologics expire, other manufacturers may produce biosimilar drugs using a similar process. Due to their complex structure, biosimilars are not identical to their respective originator biologic product but are highly similar and are functionally, structurally, and clinically tested to ensure no differences in health outcomes and safety.

Because biologic originator drugs are manufactured using living organisms with some inherent variability, there are also very small differences between different batches of the same originator drug. These differences, like those between a biosimilar and its originator, are not clinically meaningful and every batch is tested to ensure safety and efficacy.

Although biologics help treat patients with serious diseases including some autoimmune diseases, they are complex drugs and can be very expensive and time consuming to develop. The biologic drugs being switched (Enbrel®, Remicade®, and Lantus®) represent some of the largest drug expenditures in B.C.

Since biosimilars are developed based on previous biologic work and require far less research and development, they are less expensive to produce, don’t compromise efficacy and safety, and offer major cost savings that can be reinvested into our healthcare system. A healthy and competitive drug market can support more manufacturers to produce new and affordable drugs and improve access to these medicines for many patients.

Health Canada is responsible for monitoring the safety, efficacy, and quality of all new drugs on the market including biologics and biosimilars. For a biosimilar drug to be approved in Canada, Health Canada must find no meaningful differences in safety and efficacy compared to the biologic originator. The biosimilars involved in PharmaCare’s Biosimilars Initiative have been approved by Health Canada and are already in widespread use.

If you are covered by PharmaCare and you take Enbrel®, Remicade®, or Lantus® for the indications shown in the table below, you must switch to the biosimilar version of your medication before the end of the designated switch period to avoid any disruption to your coverage.

Drug

Originator

Biosimilar

Indications Affected

Switch Period

insulin glargine

Lantus ®

Basaglar ™

Diabetes (Type 1 and 2)

May 27, 2019 -

November 25, 2019

etanercept

Enbrel ®

Brenzys ®

Ankylosing spondylitis

Rheumatoid arthritis

Erelzi ™

Ankylosing spondylitis

Psoriatic arthritis*

Rheumatoid arthritis

infliximab

Remicade ®

Inflectra ®

Renflexis ®

Ankylosing spondylitis

Plaque psoriasis

Psoriatic arthritis

Rheumatoid arthritis

Crohn's disease**

Ulcerative colitis**

September 5, 2019 -

March 5, 2020

*Of the two etanercept biosimilars, only Erelzi is currently indicated for psoriatic arthritis.
**Pediatric patients on Remicade will be switched to an infliximab biosimilar. PharmaCare is working closely with B.C. Children's Hospital to accomplish this, and pediatric patients may not be switched on the same timeline as adult patients.

If you take a biologic for a gastrointestinal condition like Crohn’s disease or ulcerative colitis, you will need to switch to a biosimilar between September 5, 2019 - March 5, 2020. Talk to your gastroenterologist for more information.

Though a biosimilar is not identical to an originator drug, there are no meaningful differences between them. The safety, efficacy, and similar health outcomes of biosimilars is evidenced by a large body of clinical studies. Health Canada expects no clinical differences between a biosimilar and its originator biologic and assures patient and health professionals that biosimilars are safe and effective for their approved indications.

The nocebo effect occurs when a patient’s negative expectations affect the treatment outcomes. A patient’s mindset can impact their symptoms and their sense of well-being. Factors that can contribute to experiencing the nocebo effect are: mental health state, language barriers, use of online media as an information source, interactions with healthcare professionals, the setting in which they receive information, and other factors outside the control of healthcare professionals.

There may be medical reasons why some patients cannot switch to a biosimilar. Your prescriber can help you determine if it is medically necessary to remain on an originator drug. They can submit a Special Authority request to ask PharmaCare to consider continued coverage of the originator drug.

Many European nations have required that patients taking biologics under publicly funded coverage plans switch to biosimilars. These patients have been tracked and followed in many studies. The clinical trials and registry data findings are regularly reported at the European League Against Rheumatism (EULAR) and American College of Rheumatology (ACR) annual scientific meetings. There are now more than 75 research studies in rheumatology, gastroenterology, dermatology and other diseases, which collectively show no meaningful clinical differences for the majority of patients after a switch from an originator biologic to its biosimilar.

These studies also found that efficacy loss associated with switching to biosimilars was the same as is expected for patients who remain on the originator drug.

The Ministry of Health will be carefully monitoring drug usage, patient outcomes, and feedback from patients and healthcare practitioners both during and after the Biosimilars Initiative.

To minimize the impact of the Biosimilars Initiative, biosimilar manufacturers are providing patient support programs (PSP) and services, and access to infusion centres similar to that of the originator drug (see below). Your prescriber can initiate the enrolment process into a PSP for you, if applicable.

Inflectra

The Inflectra Patient Assistance Program provides support services and coordination with private payers and infusion centres for patients taking Inflectra®.

Erelzi

The Erelzi XPOSE® program provides support services, including self-injection training, for patients taking Erelzi™. Both the prescriber and patient must complete and sign an enrolment form to enroll in the program.

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